Barrett's esophagus results from Gastroesophageal Reflux Disease (GERD) and affects approximately 3 million patients in the United States, with 86,000 new cases being diagnosed each year. Aldulaimi et al., Eur J Gastroenterol Hepatol. 2005 September; 17(9):943-50, discloses that a diagnosis of Barrett's esophagus predisposes patients to develop esophageal adenocarcinoma with a risk calculated as 30-125 times more as compared to patients without a diagnosis. Esophageal adenocarcinoma develops in a defined sequence of changes from benign, to low grade dysplasia, to high-grade dysplasia, and to malignant cancer.
Patients with Barrett's esophagus are frequently screened (every 3 months to every 3 years depending on stage of disease) by endoscopy and biopsies are taken for histopathology. Biopsies are analyzed by manual microscopy analysis with traditional Hematoxylin and Eosin-staining of tissue sections. Diagnosis of Barrett's esophagus is based on established histologic criteria and a minimal set of biomarkers measured singly to detect abnormalities.
The screening process has many limitations. For instance, diagnosis of Barrett's esophagus can be characterized in different stages such as low-grade dysplasia, high-grade dysplasia, and reactive atypia. These “stages” of BE share histological features and are difficult to distinguish using current H&E-based analysis. Frequently, the diagnosis results in “indeterminate/indefinite,” misdiagnosis, delayed diagnosis or inappropriate treatment. Furthermore, the current form of histology analysis is insufficient to diagnose the various stages of the BE disease accurately and to predict progression to higher disease stages.
There is a need for pathology informatics/descriptive features of BE to integrate biomarker data, morphological data around a tissue sample, and clinical data into decision-making indices. There is also a need for more accurate diagnostic, prognostic and predictive testing to guide clinical management and prevention of malignant forms of gastrointestinal cancer. There is a need for increased surveillance and stratification BE staging and prediction of effective treatments or prevention of malignant cancer. The invention relates to a system, an apparatus, a composition, a device and method of using the same to extract specific biomarker information from cell samples to improve the accuracy of diagnosis, to enable predictions of disease progression and cancer development, to predict responsiveness to therapeutic interventions, and to improve management of BE or any cancer derived from tissue diagnosed as BE.